MAUDE Adverse Event Report: Abbott Medical TriClip G5 Delivery System; tricuspid valve repair device, percutaneously delivered

Model Number	TCDS0801-XTW
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury

• Brand Name: TriClip G5 Delivery System
• Common Device Name: tricuspid valve repair device, percutaneously delivered
• Manufacturer (Section D): Abbott Medical; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50875731
• Report Number: 2135147-2026-06454
• Device Sequence Number: 10690785
• Product Code: NPS
• UDI-Device Identifier: 05415067050731
• UDI-Public: (01)05415067050731(17)270819(10)60219R2046
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P230007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TCDS0801-XTW
• Device Catalogue Number: TCDS0801-XTW
• Device Lot Number: 60219R2046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White